BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515NAB PRDGM INS V2.1 BL EN

    MDR report key: 1180065 · Received September 26, 2008

    Report

    Report Number
    3004209178-2008-00780
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 120 MG/DL. IT WAS ALSO REPORTED THAT THE INSULIN PUMP ALARMED DURING BASAL. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED CUSTOMER TO DISCONNECT FROM THE DEVICE AND REVERT TO BACK UP PLAN OF MANUAL INJECTIONS. THE WIFE STATED THAT THE ALARMS OCCURRED A MONTH AGO DURING A MANUAL PRIME, AND THE CUSTOMER WAS CONNECTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515NAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-515NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization